FDA product code HXB: Probe
HXB is the FDA product code for probe. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 15 510(k) submissions under HXB, from 13 different applicants. The average 510(k) review took 46 days (median 27). FDA has posted 3 recalls for HXB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Probe |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HXB clearance
Top HXB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthropedics, Inc. | 2 | 1987-11-02 |
| Stainless Mfg., Inc. | 2 | 1984-06-19 |
| Kinetikos Medical, Inc. | 1 | 1996-07-23 |
| Cohort Medical Products Group, Inc. | 1 | 1994-10-20 |
| Flexmedics | 1 | 1991-09-24 |
8 more applicants have HXB clearances. See the full list in Caduvo.
Most recent HXB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960539 | Kinetikos Medical, Inc. | DIAO HAND SURGERY SET | 1996-07-23 | 167 |
| K943472 | Cohort Medical Products Group, Inc. | COHORT AVB RETRACTOR SYSTEM | 1994-10-20 | 93 |
| K912843 | Flexmedics | FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE | 1991-09-24 | 90 |
| K890227 | Kinetic Medical Products | SURGICAL PROBE | 1989-01-27 | 9 |
| K873651 | Arthropedics, Inc. | BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 | 1987-11-02 | 53 |
Recalls for HXB devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code HXB?
HXB is the FDA product code for probe. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HXB?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HXB?
Across 15 cleared submissions the average was 46 days from receipt to decision (median 27).
Which companies have the most HXB clearances?
Arthropedics, Inc. (2); Stainless Mfg., Inc. (2); Kinetikos Medical, Inc. (1); Cohort Medical Products Group, Inc. (1); Flexmedics (1).
Have HXB devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HXB
- Run a recall and safety report across every HXB manufacturer
- Watch product code HXB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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